Transcript Options for Early Pregnancy Loss

Options for Early Pregnancy Loss:
Manual Vacuum Aspiration and
Medication Management
Association of Reproductive Health
Professionals
www.arhp.org
Expert Medical Advisory Committee
• Herbert P. Brown, MD
• Michelle Forcier, MD, MPH
• Emily Godfrey, MD, MPH
• Marji Gold, MD
• Jini Tanenhaus, PA, MA
Learning Objectives
• List four clinical indications for manual
vacuum aspiration (MVA)
• List four factors to consider when counseling
women about MVA versus medical
management of early pregnancy loss
more…
Learning Objectives (continued)
• List three conditions in a patient that should
cause a provider to use caution before
providing MVA or medical management of
early pregnancy loss
• List at least one medication regimen used for
early medication abortion
Module 1:
Manual Vacuum Aspiration Overview
Incidence of Early Pregnancy Loss
≤ 20 weeks’
gestation
12%–24% of
pregnancies
600,000
to 800,000
annually
Griebel CP, et al. Am Fam Physician. 2005.; Everett C. BMJ. 1997.
Smith NC. Contemp Rev Obstet Gynecol. 1988.; Stirrat GM. Lancet. 1990.
What Is a Manual Vacuum Aspirator?
Manual vacuum aspirator
• Has locking valve
• Is portable and reusable
• Vacuum is equivalent to electric
pump
• Efficacy is same as electric
vacuum (98%–99%)
• Has semi-flexible plastic cannula
Creinin MD, et al. Obstet Gynecol Surv. 2001. ; Goldberg AB, et al. Obstet
Gynecol. 2004.; Hemlin J, et al. Acta Obstet Gynecol Scand. 2001.
History of MVA
1973:
Helms Amendment
enacted
1980s:
MVA marketed
worldwide
1973:
USAID sponsors Ipas
1990s:
MVA used in
>100 countries
Bird ST, et al. Contraception. 2003. ; Edwards J, Creinin MD. Curr Probl
Obstet Gynecol Fertil. 1997.; Karman H, Potts M. Lancet. 1972.
Comparison of EVA to MVA*
Vacuum
Noise
Portable
Cannula
Capacity
EVA
Electric pump
Variable
Not easily
4–16 mm
350–1,200 cc
Suction
Constant
* Elective abortion
Dean G, et al. Contraception. 2003.
MVA
Manual aspirator
Quiet
Yes
4–12 mm
60 cc
Decreases to 80% (50 mL)
as aspirator fills
Products of Conception (POC)
Procedure is complete when POC are
identified
Electric Suction
Machine
Edwards J, Carson SA. Am J Obstet Gynecol. 1997.
MacIsaac L, Darney P. Am J Obstet Gynecol. 2000.
MVA
Aspirator
Using MVA for treatment/completion
of spontaneous abortion
• Treatment for spontaneous abortion
• Ensures POC are fully evacuated
• Comfortable for woman due to low noise level
• Portable for use in physician office familiar to
the woman
• Women very satisfied with method
▪
Very few studies on MVA in spontaneous abortion
MVA Label. Ipas. 2007.
Complications with MVA
• Very rare
• Same as EVA
• May include:
▪
▪
▪
▪
▪
Incomplete evacuation
Uterine or cervical injury
Infection
Hemorrhage
Vagal reaction
MVA Label. Ipas. 2007.
MVA vs. EVA Complication Rates
Methods
• Vacuum aspiration for abortion up to 10 wks
LMP
• Retrospective cohort analysis
• Choice of method (MVA vs. EVA) up to
physician
• n = 1,002 for MVA; n = 724 for EVA
• Charts reviewed for complications
more…
Goldberg AB, et al. Obstet Gynecol. 2004.
MVA vs. EVA Complication Rates
(continued)
Complications
• 2.5% for MVA
• 2.1% for EVA (p = 0.56)
• No significant difference
more…
Goldberg AB, et al. Obstet Gynecol. 2004.
MVA vs. EVA Complication Rates
(continued)
Choice of MVA vs EVA in
procedures
• Attendings:
52% MVA
• Gyn residents: 59% MVA
• Other residents: 76% MVA
(p<0.001)
Goldberg AB, et al. Obstet Gynecol. 2004.
Early Abortion with MVA: Study
• Methods
▪
▪
2,399 MVA procedures, < 6 weeks LMP
Meticulous inspection of products of conception
immediately after MVA
• Results
▪
▪
▪
99.2% effective in terminating pregnancy
6 repeat aspirations (0.25%)
14 ectopic pregnancies (0.6%) diagnosed &
treated
Edwards J, Creinin MD. Curr Probl OIbstet Gynecol Fertil. 1997.
Early Abortion with MVA or EVA:
Study
Methods
• 1,132 women, ≤ 6 weeks LMP
• 1,093 procedures:
▪
▪
▪
52% MVA
40% EVA
8% both
• Examination of POC immediately after
procedure
more…
Paul ME, et al. Am J Obstet Gynecol. 2002.
Early Abortion with MVA or EVA:
Study (continued)
Results
Required re-aspiration
2.3% of study population
more…
Paul ME, et al. Am J Obstet Gynecol. 2002.
Early Abortion with MVA or EVA:
Study (continued)
Failure rates by technique among women with
follow-up (95% CI):
1.1%
2.9%
7.5%
(0.4%-3.0%)
(1.4%-5.7%)
(2.1%-18.2%)
EVA
Both used
MVA
more…
Paul ME, et al. Am J Obstet Gynecol. 2002.
Early Abortion with MVA or EVA:
Study (continued)
Of the 750 women who had follow-up,
13 experienced other complications:
• 4 incomplete abortions
• 2 unrecognized ectopic pregnancies
• 1 hematometra
• 4 pelvic infections
• 3 re-aspirations for pain and bleeding
despite negative pathology
Paul ME, et al. Am J Obstet Gynecol. 2002.
MVA and POC: Study
• In group overall
▪
n = 1,726, up to 10 weeks LMP
• Complication rates between MVA and EVA
▪
▪
▪
37 patients at < 6 weeks’ gestation
In 35 of 37, provider chose MVA
No re-aspirations needed in patients < 6 weeks
more…
Goldberg AB, et al. Obstet Gynecol. 2004.
MVA and POC: Study (continued)
“…Significantly more re-aspirations
for inability to accurately identify the
pregnancy occurred in electric group.”
Goldberg AB et al.
Obstet Gynecol, 2004
Goldberg AB, et al. Obstet Gynecol. 2004.
Safety and Efficacy:
Family Practice Office
Methods
• Abortion using MVA, <12 weeks LMP
• Retrospective chart review, N = 1677
• 60% performed by residents under
supervision
• 40% performed by attendings
more…
Westfall JM, et al. Arch Fam Med. 1998.
Safety and Efficacy:
Family Practice Office (continued)
Results
• 99.5% effective
• 1.3% minor complications
• No hospitalizations
Westfall JM, et al. Arch Fam Med. 1998.
Patient Satisfaction
• Both EVA and MVA groups highly satisfied
• No differences in:
▪
▪
▪
▪
▪
Pain
Anxiety
Bleeding
Acceptability
Satisfaction*
• More EVA patients bothered by noise
Bird ST, et al. Contraception. 2003. ; Dean G, et al. Contraception. 2003.
Edelman A, et al. Am J Obstet Gynecol. 2001.
MVA Safety and Efficacy: Summary
• MVA is simple
▪
Easily incorporated into office setting
• Training/Practice Issues
▪
▪
▪
▪
▪
Expanding pain management options
Ultrasound as needed
No sharp curettage
Patient-provider interaction
Instrument processing for multiple use
(new guidelines)
MVA in Office Settings
• Especially beneficial to women grieving
their loss
• Delivered in a comfortable setting
• Safety and efficacy equivalent to EVA
• Portable
• Simple
• Low cost
• Small and quiet
Goldberg AB, et al. Obstet Gynecol. 2004.
Module 2:
Manual Vacuum Aspiration for
Early Pregnancy Loss
MVA Steps
After counseling and support …
Gather required supplies
Charge aspirator
Stabilize and anesthetize cervix
Insert cannula
Empty uterus
MVA Instruments
Steps for Performing MVA
A step-by-step, onepage poster is
available from the
manufacturer to
guide clinicians
through the
procedure
MVA and Pain
Pain made worse by:
• Fearfulness
• Anxiety
• Depression
Belanger E, et al. Pain. 1989. ; Smith GM, et al. Am J Obstet Gynecol. 1979.
Hansen GR, Streltzer J. Emerg Med Clin N Am. 2005.
Effective Pain Management
• Respectful, informed, and supportive staff
• Warm, friendly environment
• Gentle operative technique
• Women’s involvement
• Effective pain medications
Pain Management Philosophies
• Minimize risk/maximize benefit
• Take away all pain/all feeling
• Get through it
Pain Management Techniques
With addition of:
• Focused breathing: 76%
• Visualization: 31%
• Localized massage: 14%
General or nitrous
10%
32%
Local
+ IV
58%
Local
Lichtengerg ES, et al. Contraception. 2001.
Good M, et al. Pain Manag Nurs. 2002.
Paracervical Block
Deep Injection
Regular Injection
Castleman L, Mann C. 2002.
Maltzer DS, et al. 1999.
Efficacy of Ancillary Anesthesia
• Importance of psychological preparation and
support
• Music as analgesia for abortion patients
receiving paracervical block
▪
85% who wore headphones rated pain as “0,”
compared with 52% of controls
• Verbicaine (“Vocal Local”)/Distraction
Therapy
Shapiro AG, Cohen H. Contraception. 1975.
Stubblefield PG. Suppl Int J Gynecol Obstet. 1989.
Sharp Curettage and Pain
• Often requires
increased dilatation
• Often painful
• More difficult to
reduce anesthesia
Forna F, Gulmezoglu AM. Cochrane Library. 2002.
Sharp Curettage and MVA
• Generally not indicated
• Not routinely recommended after MVA
more…
WHO, Safe Abortion: Technical and Policy Guidance for Health Systems. 2003.
Sharp Curettage and MVA (continued)
“…Health managers and policy
makers should make all possible
efforts to replace sharp curettage
(D&C) with vacuum aspiration.”
WHO, 2003
WHO, Safe Abortion: Technical and Policy Guidance for Health Systems. 2003.
Who Can Provide MVA for Early
Pregnancy Loss?
All mid-level providers
Facilities Needed for MVA
• Privacy for counseling
• Procedure room
▪
▪
Exam table
Space for supplies,
processing instruments,
and examining products
of conception
Medications and Supplies Needed
for MVA
• Analgesia
• Anesthetic
• Silver nitrate or ferric subsulfate
• Uterotonic agent
• Rhogam
more…
Medications and Supplies Needed
for MVA (continued)
• Urine pregnancy tests
• Emergency cart
• Pharmacologic agents for cervical ripening
(optional)
Equipment Needed for MVA
Procedure
• Aspirators
• Cannulae
• Speculae
• Sharp-toothed and/or atraumatic tenaculae
more…
Equipment Needed for MVA (continued)
Procedure
• Antiseptic solution
• Mechanical dilators
• 20-cc syringe for local anesthesia
more…
Equipment Needed for MVA (continued)
more…
Equipment Needed for MVA (continued)
Tissue examination
• Basin for POC
• Fine-mesh kitchen strainer
• Back light or enhanced light
• Tools to grasp tissue and POC
• Specimen containers
Hyman AG, Castleman L. Ipas, 2005.
MVA and Follow-up Ultrasound
POC may be harder to identify in EPL
• Use in office ultrasound or
• Follow-up ultrasound
determination performed
elsewhere
Word Health Organization. 2003.
MVA Patient Intake and Counseling
Indications for MVA
MVA is appropriate for the treatment of
incomplete abortion for uterine sizes up to
12 weeks LMP
Ipas. 2007.
Use Caution in Women with…
• Uterine anomalies
• Coagulation problems
• Active pelvic infection
• Extreme anxiety
• Any condition causing the patient to be
medically unstable
Ipas. 2007.
Counseling for MVA
Effective counseling occurs
before, during, and after the
procedure
• Woman-centered
• Structured completely
around the women’s
needs and concerns
more…
Breitbart V, Repass DC. J Am Med Womens Assoc. 2000.; Hogue CJ, et al.
Epidemiol Rev. 1982; Steward FH, et al. 2004. Hyman AG, Castleman L. 2005.
Counseling for MVA (continued)
• Prepare women for
procedure-related effects
• Address women’s concerns
about future desired
pregnancies
more…
Breitbart V, Repass DC. J Am Med Womens Assoc. 2000.; Hogue CJ, et al.
Epidemiol Rev. 1982; Steward FH, et al. 2004. Hyman AG, Castleman L. 2005.
Counseling for MVA (continued)
Quality of
counseling
Picker Institute. 1999.
Patient
satisfaction
with care
Post-Procedure Care
• Observe for complications
▪
▪
Bleeding
Pain
• Monitor pain and treat accordingly
• Monitor vital signs
• Check bleeding and pain
more…
Post-Procedure Care (continued)
• Give instructions for aftercare/follow-up
• Discuss contraception, if appropriate
• Discharge patient
▪
▪
▪
Tolerates oral intake (general anesthesia only)
Vital signs are normal
Bleeding is minimal
Lichtenberg ES, Shott S. Obstet Gynecol. 2003.
Instructions for Aftercare
• Warning signs to call a
clinician
• Pain management options
• Prophylactic antibiotics
▪
Many regimens effective
• When to return to normal
activities
Lichtenberg ES, Shott S. Obstet Gynecol. 2003.
When Women Should Contact
Clinician
• Heavy bleeding with dizziness,
lightheadedness
• Worsening pain not relieved with medication
• Flu-like symptoms lasting > 24 hours
• Fever or chills
• Syncope
• Any questions
Contraception After MVA
Ovulation may occur within 7–10 days postMVA
• Dispense EC with instructions for use
• Can start hormonal contraceptives
immediately
• Can insert IUD immediately post-procedure
more…
Contraception After MVA (continued)
• Tubal ligation can be performed postprocedure or scheduled; develop interim
contraception plan
• Barrier contraceptive use with first and
subsequent intercourse
Module 3:
Medication Management of Early
Pregnancy Loss
Regimen
• Misoprostol 800 μg vaginally
• Repeat dose on day 3 if indicated
• Offer expectant management if clinically
stable
• Consider vacuum aspiration if expulsion
incomplete
Zhang J, et al. N Engl J Med. 2005.
Creinin MD, et al. Obstet Gynecol. 2006.
Efficacy: Medication vs. Expectant
Management
Misoprostol
600 μg
vaginally
Expectant
management
(placebo)
Success by day 2
73.1%
13.5%
Success by day 7
88.5%
44.2%
Evacuation
needed
11.5%
55.8%
Bagratee JS, et al. Hum Reprod. 2004.
Efficacy: Medication Management
vs. Vacuum Aspiration
Misoprostol
Vacuum
800 μg
aspiration
vaginally (MVA or EVA)
Success by day 3
71%
--
Success by day 15
85%
90%
Success by day 30
84%
97%
Success at week 5
67%
100%
Zhang J, et al. N Engl J Med. 2005.
Safety Issues with Medication
Management
• Infection and sepsis
possible but not
reported in any EPL
situation to date
• Prolonged heavy
vaginal bleeding typical
Patient Intake Steps for Medication
Management
• Medical history
• Lab work, including -hCG
• Determine size/type tissue
• Educate about process and pain
management
• Discuss contraception
World Health Organization. 2003.
Pain Management
• Ibuprofen or acetaminophen initially
• Oral narcotics if necessary
Grimes DA, Creinin MD. Ann Intern Med. 2004.
When Women Should Contact
Clinician
• Heavy bleeding with dizziness,
lightheadedness
• Worsening pain not relieved with medication
• Flu-like symptoms lasting > 24 hours
• Fever or chills
• Syncope
• Any questions
FDA. 2006.
Follow-up After Medication
Management, Spontaneous Abortion
• Assess completion of abortion by
▪
▪
▪
Patient history
Serial HCGs or sonography
Speculum and/or bimanual exam as indicated
• Documentation of missed follow-up
• If incomplete or unsuccessful, MVA can be
used for retained POC
Module 4:
Counseling Women on MVA
Versus Medication Management
of Early Pregnancy Loss
Factors to Consider
• Duration of pregnancy
• Efficacy
• Safety
• Side effects
• Use of anesthesia
• Location
• Time required
Duration of Pregnancy
Complete expulsion (%)
Misoprostol
Vacuum aspiration
100
80
60
40
20
0
5
6
7
8
9
10
Weeks of gestation
Zhang J, et al. N Engl J Med. 2005.
11
12
Efficacy of Early Pregnancy Loss
Management Options
Complete expulsion at 30 days:
• Misoprostol (800 µg vaginally): 84%
• Vacuum aspiration: 97%
(3% of women lost to follow-up)
Zhang J, et al. N Engl J Med. 2005.
Safety of Early Pregnancy Loss
Management Options
Aspiration and medication management are
low-risk
MVA
• Uterine or
cervical injury
• Infection
Medication
• Infection
• Heavy bleeding
Stewart FH, et al. 2004.; Danco Laboratories. 2005.
FDA. 2006.; Green MF. N Engl J Med. 2005.
Expectations
Usually subside quickly
MVA
• Cramping
• Bleeding
Grimes DA, Creinin MD. Ann Intern Med. 2004.
NAF. 2006.
Medication
• Cramping
• Bleeding
• Nausea/vomiting
• Diarrhea
• Fever/chills
• Fatigue
Pain Management for Early
Pregnancy Loss Options
Women may see anesthesia as a pro or con
MVA
• Local anesthesia
• Oral premedication
NAF. 2006.
Medication
• Ibuprofen (Rx)
• Mild narcotic
Location: Where Expulsion Occurs
NAF. 2006.
MVA
Medication
Hospital or
office setting
Occurs at home
Time Required for Procedure
MVA
Medication
• Complete within
minutes
• 1 visit to provider
• Long duration
• May be up to 30
days for complete
evacuation
NAF. 2006.
MVA Training Organizations
• Association of Reproductive Health
Professionals (ARHP)
• Clinician Training Initiative (CTI)—Planned
Parenthood of New York City (PP-NYC)
• National Abortion Federation
• Planned Parenthood® Federation of
America (PPFA)
• Ipas
• Physicians for Reproductive Choice and
Health (PRCH)
Appendix
Expert Medical Advisory Committee
Herbert P. Brown, MD
Clinical Associate Professor of Ob/Gyn
University of Texas Health Science Center
San Antonio, TX
Michelle Forcier, MD, MPH
Adjunct Assistant Clinical Professor of Pediatrics
University of North Carolina School of Pediatrics and
Family Medicine and Duke University School of Pediatrics
Chapel Hill, NC
Emily Godfrey, MD, MPH
Assistant Professor, Department of Family Medicine
University of Illinois at Chicago
Chicago, IL
more…
Expert Medical Advisory Committee
(continued)
Marji Gold, MD
Professor of Family and Social Medicine
Albert Einstein College of Medicine
Bronx, NY
Jini Tanenhaus, PA, MA
Associate Vice President, Clinician Training Initiative
Planned Parenthood of New York City
New York, NY